MAUDE Adverse Event Report: Scientia Vascular Aristotle; Guidewire

Model Number	00775
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an mma embolization procedure an aristotle 14 guidewire broke inside of a patient approximately 5-7cm from the distal tip.The guidewire broke and was caught in the catheter, and surgical intervention was not required.The physician noted there was some tortuosity, but when they switched to a synchro wire there were no issues.It was reported that the event did not have any adverse impact on the patient.

• Brand Name: Aristotle
• Common Device Name: Guidewire
• Manufacturer (Section D): Scientia Vascular; 2460 south 3270 west; west valley city UT 84119
• Manufacturer (Section G): Scientia Vascular; 2460 south 3270 west; west valley city UT 84119
• Manufacturer Contact: joshua verlac ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 50897778
• Report Number: 3009546466-2026-00056
• Device Sequence Number: 14928551
• Product Code: DQX
• UDI-Device Identifier: 00818075010011
• UDI-Public: 00818075010011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00775
• Device Catalogue Number: A14-200-002
• Device Lot Number: 051654
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: J&J Cereglide Catheter.; J&J MedTech Prowler EX Microcatheter.
• Patient Sex: Unknown